Clinical Study Regulatory Coordinator

1 week ago

Toronto, Ontario, Canada University Health Network Full time
Job Title: Clinical Study Regulatory Assistant

At the University Health Network, we are seeking a highly skilled Clinical Study Regulatory Assistant to join our team. As a key member of our clinical research staff, you will play a critical role in ensuring the smooth operation of our clinical trials.

Key Responsibilities:
  • Assist the inter-professional clinical research team in performing study-specific tasks as per protocol
  • Responsible for data collection, entry, verification, and reporting
  • Enter medical data from health records or other sources, as per approved study protocol and authorized access into electronic data capture (EDC) systems
  • Identify and log protocol and SOP deviations
  • Support resolution of data queries from sponsors and issues query forms to study team or third parties
  • Support the reporting of events to Research Ethics Board as needed
  • Prepare submissions (amendments, reportable events, annual renewals, study closures) to Research Ethics Board
  • Execute study-related administrative tasks, such as collection and maintenance of regulatory documents, ethics submissions, protocols, staff training, and delegation logs in paper and electronic formats
  • Maintenance & modification of study-specific trackers and study tools (screening and enrollment worksheets, eligibility checklists)
  • Scheduling on-site/virtual monitoring visits and collecting necessary source documentation for data verification
  • Liaise between site and sponsor to ensure that all trial-related documentation and information are distributed to relevant staff involved with the trial
  • Ensure and maintain regulatory compliance for clinical research studies involving human subjects by following appropriate protocols
  • Coordinate the close-out phase of clinical study protocols as well as archival of study documents
Requirements:
  • At minimum, a completion of a Bachelor's degree program, or recognized equivalent in Health or Science Related Discipline
  • At least one (1) year experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects
  • Demonstrated relevant clinical research knowledge
  • Excellent written and verbal communication skills, excellent organization, prioritization skills, good computer skills, ability to learn quickly and work independently
  • Excellent interpersonal skills
  • Ability to work under pressure and attention to detail
  • Ability to perform duties in a professional and courteous manner and produce high-quality work while meeting deadlines in accordance with UHN standards Ability to perform multiple concurrent tasks
  • Knowledge of applicable legislative, UHN and/or departmental policies
  • Client service-oriented, with the ability to effectively work with diversity and appreciate that people with different opinions, backgrounds, and characteristics bring richness to the challenge or situation at hand
  • Satisfactory attendance
Why Work with Us:

We offer a comprehensive benefits package, competitive salary, and opportunities for professional growth and development. Our team is dedicated to providing exceptional patient care and advancing medical research. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply for this exciting opportunity.

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